Simcor

What is Simcor?

Simcor is a combination of simvastatin and niacin. Simcor can be used to reduce cholesterol and triglycerides in the blood. Simcor can be used in conjunction with a diet to reduce total cholesterol levels, LDL (bad) cholesterol, and triglycerides while increasing HDL ("good") cholesterol.

Niacin is also known as nicotinic acid. It is a B-vitamin (vitamin B3). It is found in animals and plants, but it can also be added to foods as a supplement. Niacin can also be found in multiple vitamins and nutritional supplements.

Simvastatin belongs to a class of drugs known as HMG coa Reductase Inhibitors, or "statins." Simvastatin lowers the levels of "bad cholesterol" (low-density lipoprotein, or LDL), triglycerides, and "bad" cholesterol in the blood while increasing "good cholesterol" (high-density lipoprotein, or HDL).

Warnings

Simcor should not be taken if you're allergic to simvastatin or niacin, have severe stomach ulcers, liver disease, or severe bleeding. Avoid using Simcor during pregnancy.

Do not breastfeed while taking this medicine. Simcor should not be taken with the following medications: cyclosporine, danazol, gemfibrozil, nefazodone, erythromycin, clarithromycin, itraconazole, ketoconazole, verapamil, boceprevir, and telaprevir.

Before you take this drug

Simcor should not be taken if:

• Liver disease
• Stomach ulcer;
• Severe bleeding;
• If you are breastfeeding or pregnant,

Simvastatin may cause kidney failure by causing skeletal muscle breakdown. This condition is more common in older women, in women who are pregnant or breastfeeding, and in those with kidney disease.

If you combine simvastatin with the following drugs, your risk of serious muscle problems can increase. You should not take these drugs while taking Simcor.

• Cyclosporine;
• Danazol;
• Gemfibrozil;
• Nefazodone;
• An antibiotic: clarithromycin (erythromycin), telithromycin (telithromycin),
• Antifungal medicine: fluconazole, itraconazole, ketoconazole, and posaconazole;
• Blood pressure or heart medicine: amiodarone, diltiazem, verapamil
• Hepatitis C medications: boceprevir and telaprevir
• HIV or AIDS medication: atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, and tipranavir.

Tell your doctor before you begin taking Simcor if you have been using any of the following medicines:

• Amlodipine

Tell your doctor about any of the following to ensure Simcor is right for you:

• Liver or kidney disease
• Diabetes;
• Gout;
• A thyroid disorder,
• If you consume more than two alcoholic drinks daily
• If you have been prescribed this medication instead of regular niacin (or nicotinic or nicotinamide) or vitamin supplements containing niacin,

Simcor may harm a developing baby or cause a birth defect. Avoid taking Simcor while pregnant. If you get pregnant, stop taking the medication immediately and inform your doctor. Use birth control to prevent pregnancy.

Simvastatin and niacin can pass through breast milk, which could be harmful to a nursing infant. Do not breastfeed while taking niacin or simvastatin.

How to take Simcor?

Simcor must be taken exactly as prescribed. Take all the instructions on the prescription label. Do not take more medicine or longer than your doctor has prescribed. This medication can have serious and life-threatening effects if taken in excess.

Simcor should be taken before bedtime with a low-fat snack. Please follow your doctor's advice. Take this medication on an empty stomach. No longer chew or crush the extended-release tablets. Take it as a whole.

Certain side effects of Niacin include dizziness or fainting, sweating or chills, flushing or warmth under the skin, rapid or pounding pulses, shortness of breath, or feeling as if you are about to pass out. You can make these effects worse by drinking alcohol or hot drinks shortly after taking Simcor. As you continue to take the medication, these effects will disappear.

To prevent certain side effects, your doctor may suggest that you take Simcor 30 minutes after taking aspirin. Aspirin should only be taken under the advice of a healthcare provider. Aspirin dosage should be determined by the instructions on the bottle or by your doctor.

If you:

• Uncontrolled seizures;
• An electrolyte imbalance is a high or low potassium level in the blood.
• Low blood pressure is a serious condition.
• A severe illness or infection;
• Dehydration is a condition that can occur.
• Surgery or an emergency medical situation.

Before restarting Simcor, consult your doctor if you have stopped taking it for more than 7 consecutive days. You may have to start at a lower dosage. Niacin may cause abnormal results in certain medical tests. Inform any doctor that you see about your use of this medication.

Your doctor may need to conduct regular blood tests while you take this medication. Simcor may be needed to treat high cholesterol over a longer period of time. Do not stop taking Simcor unless you are told to by your doctor. Store away from heat and moisture at room temperature.

Details on dosage

Adult dose for hyperlipidemia:

The initial dose (for patients who are not on niacin-extended-release or those on other niacin-based products than niacin-extended-release) is 500 mg–20 mg taken once daily before bedtime with a low-fat snack.Simcor 500 mg–40 mg once daily at bedtime is an option for patients who are already taking simvastatin in doses of 20–40 mg and need additional lipid management.
Maintenance (depending upon patient tolerance and lipid levels) 1000 mg-20mg to 2000 mg-40 mg once daily before bedtime, with a low-fat snack
Do not increase the dose of Niacin Extended-Release by more than 500mg daily every four weeks. Simcor doses greater than 2000 mg–40 mg daily have not been evaluated for safety and efficacy and are therefore not recommended. Re-titration is recommended if therapy is stopped for a long period (greater than seven days).

What happens if I miss the dose?

As soon as you remember a missed dose, take it immediately. If your next scheduled dosage is quickly approaching, simply skip it. You should not take more medicine to compensate for a missed dose.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Simvastatin can interact with grapefruit or grapefruit juice, causing potentially dangerous side effects. Do not drink more than one quart of grapefruit juice per day. Avoid taking cholestyramine or colestipol (Colestid) within 4 to 6 hours before or after Simcor.

Avoid foods high in cholesterol or fat. Simcor won't be as effective at lowering cholesterol if you don't follow a diet that lowers cholesterol. Avoid alcohol. Alcohol can increase triglyceride and liver damage risks.

Side effects of Simcor

If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of the face, lips, or tongue, or swelling of the throat.

In rare cases, simvastatin may cause kidney failure due to a condition resulting in skeletal muscle breakdown. If you experience unexplained weakness, muscle tenderness, or pain, call your doctor immediately, especially if there is a fever, unusual fatigue, or dark urine.

If you experience:

• Memory problems and confusion
• Weight gain and swelling with little or no urinating
• Liver problems: nausea, upper abdominal pain, itching and fatigue, loss of appetite, dark urine, clay-coloured stools, or jaundice
• High blood sugar: increased thirst, increased urination, and hunger; dry mouth with a fruity odour; drowsiness or dry skin; blurred eyesight; weight loss.

Side effects of Simcor include:

• Headache;
• Back pain
• Nausea, diarrhoea;
• If you feel flushed (warmth, tingling, or redness), then it is likely that your skin has been irritated.
• Mild itching

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

Tell your doctor if you have any new or changed medications, including those that you started or stopped taking during your Simcor treatment.

• Fenofibrate, fenofibric acids;
• Blood thinners (warfarin Coumadin Jantoven)

The list of drugs that can interact with simvastatin and niacin is not exhaustive. Included are prescription and non-prescription medicines, vitamins, and herbal products. This medication guide does not list all possible interactions.